AccessGUDID - DEVICE: 3D SCANNER TPR Option (B01612300004Z0)

GUDID

Device Identifier (DI) Information

Brand Name: 3D SCANNER TPR Option
Version or Model: 12300004Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12300004Z
Company Name: SUN NUCLEAR CORP.

Primary DI Number: B01612300004Z0
Issuing Agency: HIBCC
Commercial Distribution End Date: June 18, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 122240021 *Terms of Use

Device Description: Accessory to the 1230 3D SCANNER.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38399	Accelerator system quality assurance device	An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101992	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not store the instrument in the treatment room.
Special Storage Condition, Specify: Never leave the instrument on the couch during delivery system warm up.
Special Storage Condition, Specify: Never expose the 3D TPR electronic circuits to the direct radiation beam.
Special Storage Condition, Specify: Store 3D TPR in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify: Ensure that all 3D TPR parts, including cable and connector, are clean and dry before placing in storage case. Dry with a soft cloth. Never use abrasive cleaners.
Special Storage Condition, Specify: If connector is accidentally immersed in water, allow to dry completely before connecting to 3D SCANNER.
Special Storage Condition, Specify: Do not keep 3D TPR in water for longer than 24 hours.
Special Storage Condition, Specify: For transport and storage within the facility, 3D TPR can remain attached to the Water Tank, but it is recommended to store 3D TPR in its case when not in use.
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Handling Environment Temperature: between -30 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 18.7 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7745924d-bdd5-4773-bd14-7e5cdcbfadd1
Public Version Date: June 18, 2019
Public Version Number: 5
DI Record Publish Date: January 14, 2017